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Medicines recallMHRA

Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion Bag recalled over possible contamination

Contamination or sterilityHigh riskClass 2

Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.

Check your product

Only products that match these details are covered. Have your pack in front of you.

8 identifiers listed for this notice.

  • Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion Bag 1

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • HAF0083A
    • HAE0425A
    Product licenceThe PL number on the carton.
    • PL 31750/0193
    • PL 31750/0194
    ExpiryOn the carton, blister or label.
    • 31 December 2025
    • 31 July 2025
    First distributedOn the product, its label or its packaging.
    • 18 March 2024
    • 2 November 2023

What to do now

The concern with Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion is contamination or loss of sterility.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

Symptoms and when to get help

Look out for

  • redness, swelling or pain where the product was used
  • a high temperature

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/29). Quoted as issued.

Summary

Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.

The risk

DMRC reference number DMRC - 31045928 Company name

Advice for healthcare professionals

Stop supplying the listed batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. This medicine is being recalled as a precautionary measure and should present no direct harm to patients who have already received these batches.

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients do not have direct contact with this type of medicine as it must be administered by a healthcare professional. Patients should continue to take medicines as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients do not have direct contact with this type of medicine as it must be administered by a healthcare professional. Patients should continue to take medicines as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Open the MHRA notice

Questions

Why has Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion been recalled?

The concern with Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion is contamination or loss of sterility. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

How do I know if my medicine is affected?

Compare the batch code, product licence, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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